“There is the old adage that you cannot test quality into a product. By the same token, you cannot manage service and quality into a CDMO,” says Roger Graben, biopharma industry veteran and president of Vitruvias Therapeutics. But he’s got some sage advice on how to select your service provider, and work best within those limitations.
The first article in this series discussed the physical elements of facility design that sponsors look for in contract development and manufacturing organizations’ (CDMOs) manufacturing facilities. This second installment describes sponsors’ requirements for dedicating equipment to GMP operations, equipment redundancy, and transparency of equipment and facility issues.
The ongoing Brexit negotiations between the British Parliament and the EU has left pharma supply chain managers scrambling for cover. As recently as October 2018, the probability of a no-deal scenario was low and it made little sense to invest in or commit to alternate plans, but this changed when Parliament rejected Prime Minister Theresa May's deal in December. The politics are not as important to business as the conclusion: The best way to mitigate disruption is to more heavily weigh finding alternate ex-U.K. suppliers versus waiting it out. Negotiating deals and supply agreements takes time, as does the logistics of tech transfer and moving materials. So risk management, timing, and terms are key success factors.
ISR data, collected for the purpose of improving our understanding of the much-anticipated bioprocessing capacity crunch, reveals that it is not a matter of if or when a capacity crunch will impact the biopharmaceutical industry; instead, it’s a question of who, or which types of drug innovators, will be impacted.
Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.
Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. Following are some basics to help with planning sample collection and to help make the process as cost-effective as possible.
Over the years, an entire system called ‘cold chain supply (or cold chain transport)’ has developed in the food industry to ensure that foods that need to be kept cold are stored and transported in appropriate conditions and are monitored so consumers and regulators can be assured of their safety.
Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.
Zydis® fast dissolve formulation for Zelapar® (Selegiline anti-Parkinson’s compound) had a positive impact on the patient compliance as compared to the Selegiline traditional tablets.
To overcome many of the challenges associated with stainless steel vessels, single‑use fermentors offer an increasingly viable alternative.
Thermo Scientific HyPerforma Single-Use Fermentor is a unique, robust, and purpose-built solution for microbial fermentation applications, offering flexibility, and efficiency found in single-use systems.
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OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
Having a solid understanding of the most common API challenges can help to avoid development delays, rework, or outright failure.
Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success.
It is critical drug that manufacturers understand the differences between the formulation development approaches OVAT and QbD to mitigate risk and preserve product performance.
A company has to be able to withstand the highs and lows of biologics development. To avoid costly mistakes and wasted efforts, a company must prepare for surprises along the drug development pathway.
For small biopharma innovators, steep development costs are compounded by the fact that large molecules are becoming increasingly complex and present serious clinical or manufacturing problems.